NCT07784374

Brief Summary

This is a phase 2 study. All subjects are patients with locally advanced unresectable or metastatic pancreatic cancer harboring KRAS G12D mutation who have received at least one prior line of systemic therapy. The purpose of this study is to evaluate the anti-tumor efficacy of GFH375 plus GFH276 versus GFH375 monotherapy, and to assess the impact of GFH375 plus GFS202A versus GFH375 monotherapy on patient body weight.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_2 pancreatic-cancer

Timeline
36mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Aug 2026Aug 2029

First Submitted

Initial submission to the registry

August 10, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

August 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

August 10, 2026

Last Update Submit

September 29, 2026

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • PFS

    Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1

    Up to approximately 2 years

  • Weight

    Percentage Change in Body Weight From Baseline at Week 12

    Baseline, From first study treatment to Week 12

Secondary Outcomes (10)

  • OS

    Up to approximately 3 years

  • PFS

    Up to approximately 2 years

  • ORR

    Up to approximately 2 years

  • DCR

    Up to approximately 2 years

  • DoR

    Up to approximately 2 years

  • +5 more secondary outcomes

Study Arms (3)

GFH375+GFH276

EXPERIMENTAL
Drug: GFH375Drug: GFH276

GFH375+GFS202A

EXPERIMENTAL
Drug: GFH375Drug: GFS202A

GFH375

EXPERIMENTAL
Drug: GFH375

Interventions

GFH375DRUG

administered per protocol-specified schedule

GFH375GFH375+GFH276GFH375+GFS202A
GFH276DRUG

administered per protocol-specified schedule

GFH375+GFH276
GFS202ADRUG

administered per protocol-specified schedule

GFH375+GFS202A

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to provide written informed consent prior to any study-related procedures.
  • Male or female subjects aged between 18 and 80 years (inclusive) at the time of informed consent.
  • Histologically or cytologically confirmed pancreatic adenocarcinoma.
  • Estimated life expectancy ≥ 3 months as judged by the investigator.
  • Has received at least 1 prior line of systemic anti-tumor therapy.
  • Has at least one measurable lesion per RECIST version 1.1.
  • Adequate organ function.

You may not qualify if:

  • Other malignancy that has progressed or required treatment within 3 years prior to study entry.
  • Active central nervous system (CNS) metastases.
  • Prior treatment with KRAS G12D-specific or pan-RAS/KRAS targeted agents.
  • Clinically significant severe cardiovascular disease.
  • Stroke or other severe cerebrovascular events within 6 months prior to randomization.
  • Significant acute or chronic infectious disease.
  • Severe psychiatric disorder, history of drug abuse, or significant alcohol abuse.
  • Pregnant or lactating female subjects.
  • Other conditions that, in the investigator's opinion, make the subject unsuitable for study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Lizhi Yi +86 21 6882 1388

CONTACT

+86 21 6882 1388lzyi@genfleet.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 25, 2026

Study Start

August 20, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2029

Last Updated

October 2, 2026

Record last verified: 2026-09

Locations

CN(1)